DIN EN 46002 (1996-09)被替代
Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9002
出版：German Institute for Standardisation (Deutsches Institut für Normung)
专家解读视频
Specifies the quality requirements for the production and, where relevant, installation of medical devices. Coverage includes: quality system requirements; product identification and traceability; inspection, measuring and test equipment; control of nonconforming product; handling, storage, packaging and delivery; internal quality audits. Also gives detailed definitions.
SN EN 46002:1997 - Identical
NF EN 46002:1996 - Identical
ONORM EN 46002:1996 - Identical
BS EN 46002:1997 - Identical
I.S. EN 46002:1997 - Identical
UNE EN 46002:1996 - Identical
SS EN 46002 Ed. 2 (1997) - Identical
